FDA-TRACK: Combination Products Performance Reports
The Medical Device User Fee and Modernization Act (MDUFMA) requires the HHS Secretary to submit an annual report to Congress on the activities and impact of the Office of Combination Products (OCP). The report focuses on OCP’s efforts to ensure the prompt assignment of combination products to agency centers, timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of combination products.
These reports are prepared by FDA's Performance Management Staff (PMS) in collaboration with FDA’s Office of Combination Products, the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.
For additional information on Combination products, please go to FDA’s Office of Combination Products.